A Clinico-Pathological Study to Investigate the Possible Infective Causes of Non-Hodgkin Lymphoma of the Ocular Adnexae

Non-Hodgkin Lymphoma Clinical Trial

— IELSG27  

Official title:

A Clinico-pathological Phase II Study With Translational Elements to Investigate the Possible Infective Causes of Non-Hodgkin Lymphoma of the Ocular Adnexae With Particular Reference to Chlamydia Species and the Effects of MALT Lymphoma Treatment With Tetracycline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010295
• Other study ID #: IELSG27
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2009
• Last updated: November 22, 2013
• Start date: September 2006
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: International Extranodal Lymphoma Study Group (IELSG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: SwissmedicItaly: Ethics CommitteeSpain: Ethics CommitteeChile: Instituto de Salud Pública de Chile
• Study type: Interventional

Clinical Trial Summary

Patients with mucosa-associated lymphoid tissue (MALT) lymphoma of the ocular adnexae (MLOA) will be eligible for treatment with doxycycline (part A: clinico-pathological study); patients with other types of ocular lymphoma, inflammatory lesions or those ineligible/unwilling for treatment with doxycycline can participate in the only pathologic study (part B).

Description:

Patients with suspected lymphoma of the ocular adnexae will undergo a diagnostic biopsy in the usual way. If lymphoma is confirmed the patient will undergo a full staging evaluation and entry into either part A or B of the study will then be considered as follows:

• clinico-pathological (part A) for patients with MALT lymphoma of the ocular adnexae (MLOA) and eligible for treatment with Doxycycline 100 mg twice daily for 3 weeks ; or

• pathology only (part B) for patients with other types of ocular lymphoma, inflammatory lesions or those ineligible/unwilling for treatment with doxycycline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years or over

2. Histologically confirmed marginal zone B-cell lymphoma of MALT-type

3. Lymphoma localised to the ocular adnexae (conjunctiva, lacrimal gland, orbit soft tissue, clinical stage IEA) following a CT scan of neck, thorax, abdomen and pelvis, bone marrow aspirate/trephine, full blood count and biochemical profile

4. No previous treatment, excepting RT for localised lymphoma of the contralateral eye

5. At least one measurable lesion

6. No systemic antibiotic therapy in the last three months

7. No other malignancy in the previous 5 years apart from appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix

8. In women with reproductive potential a willingness to use contraception from entry into the study for a period of 3 months

9. Written informed consent

Exclusion Criteria:

1. Pregnant or lactating women

2. Known allergy to tetracycline

3. Patients unwilling to comply with the requirements of follow-up as defined by this protocol

4. Myasthenia gravis (tetracycline can exacerbate muscle weakness)

5. Systemic lupus erythematous (tetracycline can exacerbate the condition)

6. Patients with large or rapidly enlarging tumours requiring immediate radiotherapy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

Drug:
• doxycycline (tetracycline)
doxycycline 100 mg twice daily for 3 weeks

Locations

Country	Name	City	State
Chile	Hospital del Salvador	Providencia, Santiago
Italy	Ospedale San Raffaele, Department of Oncology	Milan
Italy	S. Matteo	Pavia
Italy	A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia	Reggio Calabria
Spain	Hospital Ramon y Cajal	Madrid
Switzerland	IOSI	Bellinzona

Sponsors (1)

Lead Sponsor	Collaborator
International Extranodal Lymphoma Study Group (IELSG)

Countries where clinical trial is conducted

Chile,  Italy,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rates		at 6 weeks, 12 weeks, 12 months and 24 months from start of doxycycline	No